Study Details

HOPE THRIVE is designed to see if a special phone app which delivers cognitive behavioral therapy digitally can help pregnant women and expectant mothers who are feeling really anxious feel better.

We want to know if using the app can help people feel less anxious and can also help them feel less stressed, sleep better, and have fewer instances of feeling sad. If you qualify for the study, you'll get to use the app for free and we'll give you $250 for your time. Some participants may also be part of a focus group discussion which comes with an additional $50 in compensation.

The study will have two groups: one will start using the app right away, and the other will wait for 10 weeks before they have app access. We choose who goes into which group by chance, like flipping a coin. This way, we can really tell if the app is helping. Before you join, we have 23 study screening questions for you to answer. The survey will take about 10 to 15 minutes to complete. Your answers will help us figure out if this study is a good fit for you. Once you're done with the questions, our team will check your answers. We'll get back to you in 1 to 7 days to let you know if you qualify for study. If you do, we'll have a quick 30-minute meeting online to tell you all about the study before you decide officially to enroll and begin the study.

To qualify for the study you must meet all of the following criteria:

• Be pregnant and between 8-27 weeks gestation by ultrasound dating
• Live in California
• Be a California MediCal participant
• Be 18-years of age or older
• Have a 9th grade education or more
• Feel comfortable speaking, reading, and writing in English
• Have daily access to web-enabled computer, smartphone, or tablet
• Have not received cognitive behavioral therapy (CBT) for anxiety or an anxiety disorder in the past 12-months
• Do not have a new or changed dose of prescription medication for anxiety, depressive symptoms, or poor sleep in < 4 weeks
• Have no self-reported diagnosis of schizophrenia, psychosis, bipolar disorder, seizure disorder, substance use disorder, or severe cognitive impairment (characterized by experiences like forgetting events, having decreased periods of alertness, decreased social awareness)
• Have no recent trauma to the head or brain damage
• Have no serious physical health concerns necessitating surgery or hospitalization in the last 6-months
• Be experiencing moderate to severe levels of anxiety

To qualify for the study it is also important that you meet the criteria above and also, that you feel comfortable making a commitment to yourself and the study with respect to required activities. If you are able to answer “yes” to the commitments to yourself and the study then you are a good candidate for the study.

Commitments to yourself:

If you can answer ”yes” to the following questions then you are a good candidate to participate:

• Is now is a good time for me to take part?
• Do I have the time to commit to this?

​​Commitment to the study:

If you can answer ”yes” to the following questions then you are a good candidate to participate:

• Are you willing to be randomized to either digital CBT now OR later (in 10-weeks)?
• Can you use the app at least one time per week if randomized to start using it soon?
• Are you willing to complete the follow-up surveys regardless of whether your anxiety gets better or worse?  This includes 5-surveys: once at enrollment, at 3-weeks after study start, at 6-weeks after study start, at 10-weeks after study start, and one at 6-8 weeks after expected date of delivery.

What will happen if I decide that I want to enroll in the study?

After enrolling in the study (by completing your consent form) you will:

• Receive a more detailed enrollment survey by email which you will complete online. This survey asks about your background, pregnancy health, and about your general health and well-being. The survey will take about 10 to 20 minutes to complete;
• In 1 to 7 days after completing your enrollment survey you will find out if you have been randomized to receive access to the dCBT app immediately or in 10 weeks;
• As a reminder, you should only consent to participate in this study if you want to be part of it regardless of whether you are randomized to start using the dCBT app now or in 10-weeks;
• If you were randomized to receive access to the app immediately, you will be sent instructions for downloading and starting to use  in the same email;
• If you were randomized to receive access to the app in 10-weeks, you will be notified that you will be sent instructions for downloading and starting to use the app in 10-weeks. This will be explained to you in the same email as report of your randomization;
• If you were randomized to start using the app immediately, once you have downloaded the app and signed up to use it, it is expected that you will use the app a minimum 1 time per week and ideally every few days;
• Reminders to use the app will be sent to you by app. You will also get a reminder from study staff once a week by text to use the app;

What does using the app involve?

The app will guide you through four core program areas designed to help you address and manage anxiety. These program areas focus on things like relaxing your body, making time to think about your worries, and exercises to help you examine your thoughts and worries.

• Initial lessons/ learning takes about 30 minutes;

• Then, ideally, you will spend 5-10 minutes every 1-2 days, for 6-weeks using the app with additional practice of techniques outside of app use;

• Weekly check-ins take place via the app with guided focus based on symptoms / improvement;

• Use of the app on at least a weekly basis (after you are given access and for 6-weeks afterwards) is required for continued study participation If you are in the group that is randomized to start using the app right away. 

Follow-up surveys

All participants, regardless of randomization grouping will receive surveys that take from 5 to 20 minutes to complete at 3-weeks, 6-weeks, and 10-weeks after the program start that ask about your health and well-being as well as about current experiencing of anxiety, stress, depression and sleep.

All participants, regardless of randomization grouping will also receive a final survey at 6-8 weeks after expected date of delivery that will take about 20 to 25 minutes to complete that asks about your health and well-being as well as about your labor and delivery experience and the health of your baby. The survey also asks about your current experience of anxiety, stress, depression and sleep.

We ask that you try and answer all questions contained in the surveys as completely as possible. The more complete the data the more able we are to learn about factors affecting pregnancy and newborn health. Keeping this in mind, however, we understand if you feel the need to skip a question that feels unusually uncomfortable or stressful. Questions related to anxiety, stress, depression, and sleep are required to be completed given their core importance to the study.

Several of the same questions are asked at different survey time points. This is because we are looking at how health and well-being may change over time and may be related to different timing in use of the dCBT app.

If you were randomized to start using the app in 10-weeks, you will be sent information about downloading the app after completing your 10-week survey and will receive reminders for use in the same way as described above for those who start using the app immediately.

Focus group participation

As part of your participation in the study, you can also choose to be considered for participation in an online focus group with 5 to 7 other study participants. This focus group will take place after completion of an initial 6-weeks of use of the app. The focus group will take approximately 60-90 minutes and will be done on a day and time that you express as being convenient for you.

Not all study participants will be invited to participate in a focus group discussion. You do not have to answer any questions that you do not want to. You will be asked to use a code name during the focus group in order to ensure that your privacy is protected.

During the focus group discussion:

• you will be asked to introduce yourself using your code name;
• you will be asked to share your overall impression of the app and to talk about your experiences in using it and whether you would recommend it for use by others;
• you will be asked whether you think use of the app helped reduce your feelings of anxiety or with other mental health challenges like with feelings of stress or depression or with sleep problems;
• you will be asked whether you felt the app was culturally appropriate in terms of approach, content, voice, and avatar use;
• you will asked to share any other thoughts or input you have about using the app;
• you will receive additional compensation for participation in this focus group (see description in the “Compensation” section below).

Compensation

As part of the study, all participants will receive free, ongoing access to the app (during the study (starting at either study enrollment or at 10 weeks after enrollment depending on your randomization group) and until 12-months after the expected date of delivery for the current pregnancy.

You will receive up to $300 in Amazon gift cards as compensations for your participation in this study. Amazon gift cards are used for this purposed because they retain their full value and do not expire. A $50 electronic gift card will be sent to you by email within 1 to 7 days after:

1) completion and submission of your enrollment survey;

2) completion and submission of your 3-week survey;

3) completion and submission of your 6-week survey;

4) completion and submission of your 10-week survey;

5) completion and submission of your 6 to 8 week postnatal survey.

Individuals participating in an online focus group will receive an additional $50 Amazon gift card delivered electronically by email within 1 to 7 days after participation.